🎤  Dr. Ginette Collazo      |  📅  August 31, 2023   |  🕒  11 AM Eastern Time US


Description:

We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program. Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though training is considered the "vaccine for mistakes" training is not responsible for most human error deviations. In order to make sure training programs are effective and can be ruled out as a root cause for human error deviations, we will discuss elements necessary when implementing/improving a training program.




Learning Objectives:

  • Learn key elements of the training program in regulated environment
  • List Key Performance Indicators related to training
  • Learn to develop a training program
  • Learn how to measure training effectiveness
  • Learn when training is responsible for human error deviations


Areas Covered In The Session:

  • GMP regulations on the training topic
  • Agencies expectations of the training program
  • Training general aspects
  • Responsibilities of the training program
  • Requirements for New employees
  • Transferred Employees
  • External Service Providers
  • Training Events
  • Skills Qualification Program (OJT)
  • Training Assessment
  • Retraining
  • Training Outline/Contents
    • GMP
    • Technical Training
    • On the Job
  • Training Frequency and Topics
  • Instructor's Qualifications
  • Training Curricula
  • Training Documentation
  • Review of Training System Effectiveness
  • Deviations related to performance


Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Training managers and coordinators
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Plant Engineers
  • Process excellence/improvement professionals
  • Industrial/process engineers
  • Compliance officers
  • General/corporate counsel


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